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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS016
Date Received07/16/2003
Decision Date08/12/2003
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1) replace the currently approved catheter kit (ap-07002) with the ip-36633 and ip-3757 kits, 2) replace ip-36633 and ip-3757 connector with codman 3000 (ap-07002) connector, and include titanium as an alternative connector material, 3) add additional components to the kit as a convenience to the physicians and 4) labeling change to the flextip plus intraspinal catheter kit instructions for use to reflect the correct catheter volume.